FDA Grants Clearance to Axial3D for INSIGHT™ Medical Image Segmentation Platform

Tuesday, August 01, 2023

Axial3D, a prominent player in medical segmentation and 3D solutions, has proudly announced that it has received FDA clearance for its automated, AI-driven, cloud-based segmentation platform. This groundbreaking platform is specifically designed for orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications. Notably, this is the second FDA clearance Axial3D has obtained for its INSIGHT™ segmentation platform, signifying a significant milestone in the healthcare industry's adoption of automation and artificial intelligence to personalize patient care.

The FDA clearance is expected to have a profound impact on streamlining production processes, particularly for medical device companies. Axial3D INSIGHT™ boasts a unique feature set, including an AWS cloud-based infrastructure, advanced AI algorithms, and sophisticated machine learning techniques. This platform efficiently converts 2D DICOM images, such as CT and MRI scans, into precise 3D visualizations, 3D print-ready files, 3D mesh files, and even 3D printed anatomical models, utilizing Stratasys print technology.

By automating the traditionally laborious and time-consuming task of manual or semi-manual image segmentation, Axial3D's platform empowers healthcare providers and medical device companies to handle a wider range of applications while saving significant time and reducing capital expenditures. With the integration of automation and AI into their workflow, healthcare professionals gain powerful tools to access patient data in 3D more easily and swiftly, resulting in improved diagnostic accuracy, treatment planning, and surgical intervention.

Moreover, the Axial INSIGHT™ platform provides medical device companies with the means to expedite their patient-specific programs by efficiently processing larger volumes of patient data using the same resources. This wealth of 3D data can then be utilized to design personalized devices and surgical kits, complete with surgical plans, models, and surgical guides, all of which can be 3D printed using a range of printers, including Stratasys systems from Digital Anatomy 3D printers to production-scale additive manufacturing systems.



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